NL-OMON44744已完成不适用
Cost-effectiveness and cost-utility of at-home infrared temperature monitoring in reducing the incidence of foot ulcer recurrence in patients with diabetes. - DIATEMP
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Diabetes mellitus;
- •2. Age 18 or above;
- •3. Peripheral neuropathy;
- •4. Recent history of a foot ulcer or foot amputation, i.e. an ulcer has been present for at least 2 weeks and has healed within four years before randomization, or a diagnosis of midfoot or forefoot Charcot neuro-osteoarthropathy;
- •5. Ability to provide informed consent;
- •6. Ambulatory status (i.e. not permanently wheel-chair bound).
- •7. The patient is treated by a podiatrist or is willing to undergo treatment by a podiatrist from the study.
排除标准
- •1. Active foot ulceration or open amputation sites.
- •2. Active Charcot neuro-osteo arthropathy.
- •3. Active foot infection, based on criteria of the PEDIS classification.
- •4. Amputation proximal to the Chopart joint in both feet.
- •5. Severe illness that would make 18-months survival unlikely, based on the clinical judgment by the physician
- •6. Concomitant severe physical or mental conditions that limit the ability to follow instructions for the study, based on the clinical judgment by the physician. This includes the inability to perform temperature measurements, without having a caretaker who can perform the temperature measurements.
- •7. Current use of home-monitoring of foot temperature.
- •8. Critical limb ischemia, based on criteria of the PEDIS classification
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